[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100606204":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":29,"centralContacts":30,"locations":36,"responsibleParty":299,"collaborators":29,"id":301,"slug":29,"hasResults":302,"nctId":303,"briefTitle":304,"officialTitle":305,"acronym":306,"eligibilityCriteria":307,"healthyVolunteers":302,"sex":308,"minAge":309,"maxAge":310,"enrollmentInfo":311,"targetDuration":29,"studyType":314,"phases":315,"briefSummary":317,"conditions":318,"keywords":323,"overallStatus":39,"whyStopped":29,"lastUpdateSubmitDate":325,"lastUpdatePostDateStruct":326,"startDateStruct":329,"completionDateStruct":331,"leadSponsor":333,"locationsCount":334},{"fullName":5,"class":6},"Xenon Pharmaceuticals Inc.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Azetukalner","EXPERIMENTAL","Azetukalner 20 mg",[13],"Drug: Azetukalner",{"label":15,"type":16,"description":15,"interventionNames":17},"Placebo","PLACEBO_COMPARATOR",[18],"Drug: Placebo",[20,26],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","Azetukalner 20 mg taken orally once a day with food (with the evening meal when possible) for 6 weeks",[9],[25],"XEN1101",{"type":21,"name":15,"description":27,"armGroupLabels":28,"otherNames":29},"Placebo taken orally once a day with food (with the evening meal when possible) for 6 weeks",[15],null,[31],{"name":32,"role":33,"phone":34,"phoneExt":29,"email":35},"Xenon Medical Affairs","CONTACT","1-604-484-3300","XenonCares@xenon-pharma.com",[37,50,60,69,79,88,97,103,111,121,130,139,148,158,164,173,182,192,202,212,222,232,241,251,261,270,280,289],{"facility":38,"status":39,"city":40,"state":41,"zip":42,"country":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":29},"Noble Clinical Research","RECRUITING","Tucson","Arizona","85704","United States",{"type":45,"coordinates":46},"Point",[47,48],-110.92648,32.22174,{"lat":48,"lon":47},{"facility":51,"status":39,"city":52,"state":53,"zip":54,"country":43,"cosmosGeoPoint":55,"geoPoint":59,"contacts":29},"Woodland International Research Group","Little Rock","Arkansas","72211",{"type":45,"coordinates":56},[57,58],-92.28959,34.74648,{"lat":58,"lon":57},{"facility":61,"status":39,"city":62,"state":53,"zip":63,"country":43,"cosmosGeoPoint":64,"geoPoint":68,"contacts":29},"Woodland Research Northwest","Rogers","72758",{"type":45,"coordinates":65},[66,67],-94.11854,36.33202,{"lat":67,"lon":66},{"facility":70,"status":39,"city":71,"state":72,"zip":73,"country":43,"cosmosGeoPoint":74,"geoPoint":78,"contacts":29},"Clinical Innovations Inc","Bellflower","California","90706",{"type":45,"coordinates":75},[76,77],-118.11701,33.88168,{"lat":77,"lon":76},{"facility":80,"status":39,"city":81,"state":72,"zip":82,"country":43,"cosmosGeoPoint":83,"geoPoint":87,"contacts":29},"ProScience Research Group","Culver City","90230",{"type":45,"coordinates":84},[85,86],-118.39647,34.02112,{"lat":86,"lon":85},{"facility":89,"status":39,"city":90,"state":72,"zip":91,"country":43,"cosmosGeoPoint":92,"geoPoint":96,"contacts":29},"ATP Clinical Research","Orange","92866",{"type":45,"coordinates":93},[94,95],-117.85311,33.78779,{"lat":95,"lon":94},{"facility":98,"status":39,"city":90,"state":72,"zip":99,"country":43,"cosmosGeoPoint":100,"geoPoint":102,"contacts":29},"NRC Research Institute","92868",{"type":45,"coordinates":101},[94,95],{"lat":95,"lon":94},{"facility":70,"status":39,"city":104,"state":72,"zip":105,"country":43,"cosmosGeoPoint":106,"geoPoint":110,"contacts":29},"Riverside","92506",{"type":45,"coordinates":107},[108,109],-117.39616,33.95335,{"lat":109,"lon":108},{"facility":112,"status":39,"city":113,"state":114,"zip":115,"country":43,"cosmosGeoPoint":116,"geoPoint":120,"contacts":29},"PharmaSouth Research, LLC","Coral Gables","Florida","33146",{"type":45,"coordinates":117},[118,119],-80.26838,25.72149,{"lat":119,"lon":118},{"facility":122,"status":39,"city":123,"state":114,"zip":124,"country":43,"cosmosGeoPoint":125,"geoPoint":129,"contacts":29},"Clinical Neuroscience Solutions, Inc.","Jacksonville","32256",{"type":45,"coordinates":126},[127,128],-81.65565,30.33218,{"lat":128,"lon":127},{"facility":131,"status":39,"city":132,"state":114,"zip":133,"country":43,"cosmosGeoPoint":134,"geoPoint":138,"contacts":29},"Central Miami Medical Institute","Miami","33125",{"type":45,"coordinates":135},[136,137],-80.19366,25.77427,{"lat":137,"lon":136},{"facility":140,"status":39,"city":141,"state":114,"zip":142,"country":43,"cosmosGeoPoint":143,"geoPoint":147,"contacts":29},"Clinical Neuroscience Solutions, Inc","Orlando","32801",{"type":45,"coordinates":144},[145,146],-81.37924,28.53834,{"lat":146,"lon":145},{"facility":149,"status":39,"city":150,"state":151,"zip":152,"country":43,"cosmosGeoPoint":153,"geoPoint":157,"contacts":29},"Synexus Clinical Research, Inc.","Atlanta","Georgia","30328",{"type":45,"coordinates":154},[155,156],-84.38798,33.749,{"lat":156,"lon":155},{"facility":159,"status":39,"city":150,"state":151,"zip":160,"country":43,"cosmosGeoPoint":161,"geoPoint":163,"contacts":29},"Atlanta Center for Medical Research","30331",{"type":45,"coordinates":162},[155,156],{"lat":156,"lon":155},{"facility":165,"status":39,"city":166,"state":151,"zip":167,"country":43,"cosmosGeoPoint":168,"geoPoint":172,"contacts":29},"CenExel iResearch","Decatur","30030",{"type":45,"coordinates":169},[170,171],-84.29631,33.77483,{"lat":171,"lon":170},{"facility":174,"status":39,"city":175,"state":151,"zip":176,"country":43,"cosmosGeoPoint":177,"geoPoint":181,"contacts":29},"Denali Health Atlanta, LLC","Stone Mountain","30083",{"type":45,"coordinates":178},[179,180],-84.1702,33.80816,{"lat":180,"lon":179},{"facility":183,"status":39,"city":184,"state":185,"zip":186,"country":43,"cosmosGeoPoint":187,"geoPoint":191,"contacts":29},"Advanced Quality Medical Research","Orland Park","Illinois","60462",{"type":45,"coordinates":188},[189,190],-87.85394,41.63031,{"lat":190,"lon":189},{"facility":193,"status":39,"city":194,"state":195,"zip":196,"country":43,"cosmosGeoPoint":197,"geoPoint":201,"contacts":29},"Psychiatric Care and Research Center","O'Fallon","Missouri","63368",{"type":45,"coordinates":198},[199,200],-90.69985,38.81061,{"lat":200,"lon":199},{"facility":203,"status":39,"city":204,"state":205,"zip":206,"country":43,"cosmosGeoPoint":207,"geoPoint":211,"contacts":29},"Redbird Clinical Research, LLC","Las Vegas","Nevada","89119",{"type":45,"coordinates":208},[209,210],-115.13722,36.17497,{"lat":210,"lon":209},{"facility":213,"status":39,"city":214,"state":215,"zip":216,"country":43,"cosmosGeoPoint":217,"geoPoint":221,"contacts":29},"Lumina Clinical Research Center","Cherry Hill","New Jersey","08002",{"type":45,"coordinates":218},[219,220],-75.03073,39.93484,{"lat":220,"lon":219},{"facility":223,"status":39,"city":224,"state":225,"zip":226,"country":43,"cosmosGeoPoint":227,"geoPoint":231,"contacts":29},"Integrative Clinical Trials LLC","Brooklyn","New York","11229",{"type":45,"coordinates":228},[229,230],-73.94958,40.6501,{"lat":230,"lon":229},{"facility":233,"status":39,"city":234,"state":225,"zip":235,"country":43,"cosmosGeoPoint":236,"geoPoint":240,"contacts":29},"Neurobehavioral Research Inc","Cedarhurst","11516",{"type":45,"coordinates":237},[238,239],-73.7243,40.62288,{"lat":239,"lon":238},{"facility":242,"status":39,"city":243,"state":244,"zip":245,"country":43,"cosmosGeoPoint":246,"geoPoint":250,"contacts":29},"DelRicht Research","Charlotte","North Carolina","28210",{"type":45,"coordinates":247},[248,249],-80.84313,35.22709,{"lat":249,"lon":248},{"facility":252,"status":39,"city":253,"state":254,"zip":255,"country":43,"cosmosGeoPoint":256,"geoPoint":260,"contacts":29},"Lehigh Center for Clinical Research","Allentown","Pennsylvania","18103",{"type":45,"coordinates":257},[258,259],-75.49018,40.60843,{"lat":259,"lon":258},{"facility":140,"status":39,"city":262,"state":263,"zip":264,"country":43,"cosmosGeoPoint":265,"geoPoint":269,"contacts":29},"Memphis","Tennessee","38119",{"type":45,"coordinates":266},[267,268],-90.04898,35.14953,{"lat":268,"lon":267},{"facility":271,"status":39,"city":272,"state":273,"zip":274,"country":43,"cosmosGeoPoint":275,"geoPoint":279,"contacts":29},"Elevate Synapsis, LLC","Atascocita","Texas","77346",{"type":45,"coordinates":276},[277,278],-95.1766,29.99883,{"lat":278,"lon":277},{"facility":281,"status":39,"city":282,"state":273,"zip":283,"country":43,"cosmosGeoPoint":284,"geoPoint":288,"contacts":29},"Grayline Research Center","Wichita Falls","76309",{"type":45,"coordinates":285},[286,287],-98.49339,33.91371,{"lat":287,"lon":286},{"facility":290,"status":39,"city":291,"state":292,"zip":293,"country":43,"cosmosGeoPoint":294,"geoPoint":298,"contacts":29},"Core Clinical Research","Everett","Washington","98201",{"type":45,"coordinates":295},[296,297],-122.20208,47.97898,{"lat":297,"lon":296},{"type":300,"investigatorFullName":29,"investigatorTitle":29,"investigatorAffiliation":29,"oldNameTitle":29,"oldOrganization":29},"SPONSOR","100606204",false,"NCT07172516","A Randomized Study of Azetukalner Versus Placebo in Depressive Episodes Associated With Bipolar I or II Disorder (Bipolar Depression)","A Phase 3, Randomized, Double-blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Azetukalner in Depressive Episodes Associated With Bipolar I or II Disorder (Bipolar Depression)","X-CEED","Key Inclusion Criteria:\n\n* Adults ≥18 and ≤74 years of age who experienced their first major depressive episode (MDE) prior to 50 years of age.\n* Body Mass Index (BMI) ≥18 kg\u002Fm2 and ≤40 kg\u002Fm2.\n* Meets the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) criteria for bipolar I or II disorder and is currently in a MDE, confirmed using the Mini International Neuropsychiatric Interview (MINI).\n* Current MDE must has a duration of ≥4 weeks and ≤12 months.\n\nKey Exclusion Criteria:\n\n* Participant has any type of major depressive disorder (MDD) diagnosis, including MDD with psychotic features, MDD with catatonia, MDD with seasonal pattern, or postpartum depression.\n* Participant has any nonbipolar psychiatric diagnosis.\n* Participant has a substance use disorder (excluding tobacco) within the 6 months prior to screening visit.\n* Participant has a symptomatic eating disorder within the 12 months prior to screening visit.\n* Participant has a Young Mania Rating Scale (YMRS) score \\>12 points at screening visit or randomization.\n* Participant has been hospitalized for mania within the 30 days prior to screening visit.\n* Participant is considered treatment-resistant in the current bipolar depressive episode, defined as having treatment resistance (no remission) to ≥2 different medications approved by the regional regulatory authority at an adequate dose (per regulatory approved label) and for an adequate duration (at least 6 weeks).\n* Participant has had an active suicidal plan\u002Fintent within the 6 months prior to screening, presence of suicidal behavior in the last 12 months.\n* Participant has self-injurious behavior without intent to die in the 12 months prior to screening.\n* Participant has used antidepressants, mood stabilizers, anticonvulsants, antipsychotics, or other prohibited medications within the 1 week or within a period less than 5 times the drug's half-life, whichever is longer prior to randomization.\n* Participants with medical conditions that may interfere with the purpose or conduct of the study.\n* Participant is pregnant, breastfeeding, or planning to become pregnant.","ALL","18 Years","74 Years",{"count":312,"type":313},400,"ESTIMATED","INTERVENTIONAL",[316],"PHASE3","X-CEED is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of azetukalner in adult participants diagnosed with bipolar I or II disorder who are currently in a depressive episode (bipolar depression).",[319,320,321,322],"Bipolar Disorder","Bipolar Depression","Bipolar I Disorder","Bipolar II Disorder",[324,25,9],"Bipolar","2026-06-01",{"date":327,"type":328},"2026-06-03","ACTUAL",{"date":330,"type":328},"2025-08-08",{"date":332,"type":313},"2028-08",{"name":5,"class":6},28]